ORBIT GALAXY ENPOWER XTRASOFT 641CX2525Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10878528008900), received between Jun 1, 2017 and Mar 6, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult To Position” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2018Difficult to Remove; Unraveled Material; Physical Resistance; Difficult to Remove; Unraveled Material; Physical Resistance

  AS REPORTED BY AN AFFILIATE, DURING A COIL EMBOLIZATION TO AN ANEURYSM OF THE ANTERIOR COMMUNICATING ARTERY (ACOM), THERE WAS SO MUCH OF RESISTANCE WHILE PUSHING THE G2 COMPLEX XTRASOFT COIL (641CX2525, P10067) INTO THE ECHELON10 MICROCATHETER (MC). THERE WERE DIFFICULTIES REMOVING THE COIL FROM THE PATIENT, THE COIL BECAME STRETCHED. THEREFORE, BOTH THE COIL WITH THE MICROCATHETER WERE REMOVED AND THERE WAS LOSS OF CEREBRAL TARGET POSITION. THE MC WAS PLACED AGAIN AT THE TARGET SITE. THERE WAS A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OF AROUND 8-10 MINUTES. THERE WAS NO PATIENT INJURY REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS. THERE WAS NO EXCESSIVE FORCE USED AT ANY TIME DURING THE PROCEDURE. PRIOR TO THIS COIL, 4 OTHER COILS WERE DEPLOYED USING THE SAME MC WITHOUT RESISTANCE. THERE WERE NO KINKS IN THE MC THAT MAY HAVE CONTRIBUTED TO THE EVENT. ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE CATHETER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7317296 ↗
• MalfunctionJun 1, 2017Fracture; Difficult To Position; Fracture; Difficult To Position

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT POSITIONING DIFFICULTY WAS EXPERIENCED WITH ORBIT GALAXY G2 COIL (B)(4) DURING THE PROCEDURE WHICH THEN GOT DAMAGED. THE COIL WAS ATTEMPTED TO BE PLACED TWICE HOWEVER THE ATTEMPTS FAILED. THE COIL NOT CONFORMING TO THE WALLS OF THE ANEURYSM WHEN THE PHYSICIAN WAS TRYING TO POSITION IT. THE COIL WAS THEN TAKEN OUT; WHEN BEING REMOVED THE COMPLAINT COIL CRACKED. THE TARGET VESSEL FOR THE PROCEDURE WAS LEFT INTERNAL CAROTID ARTERY. THE PROCEDURE WAS NOT DELAYED DUE TO THE REPORTED EVENT AND THE PATIENT OUTCOME WAS REPORTED BE GOOD. THE PATIENT WAS A (B)(6) FEMALE WITH HISTORY OF HYPERTENSION. THE PROCEDURE WAS COMPLETED USING A SAME LIKE PRODUCT. THERE WERE NO DAMAGES NOTED ON THE COMPLAINT COIL OR THE CONCOMITANT DEVICES PRIOR TO USE OR UPON REMOVAL. IT WAS INITIALLY REPORTED THAT THE COMPLAINT PRODUCT IS AVAILABLE FOR RETURN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6604229 ↗